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Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

Primary Purpose

Gastro-esophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Protein supplement
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro-esophageal Cancer focused on measuring Exercise oncology, Resistance exercise, Cancer, Cancer cachexia, Protein supplements, Sarcopenia, Palliative chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction referred to first line chemotherapy. Exclusion Criteria: Age < 18 Living outside the greater Copenhagen area Any other malignancy requiring active treatment Not eligible for chemotherapy Performance status > 2 Not able to swallow liquids Parenteral nutrition or enteral nutrition via feeding tube Physical or mental disabilities that prohibit execution of test or training procedures Pregnancy Inability to understand the Danish language

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care Control

Exercise and protein supplements intervention group

Arm Description

Participants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.

Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. The intervention consists of resistance training and a daily protein supplement.

Outcomes

Primary Outcome Measures

Exercise feasibility: Exercise sessions attendance
The number of attended exercise training sessions relative to the number of planed exercise sessions
Exercise feasibility: Relative dose-intensity of protein supplement
The actual amount consumed relative to the amount prescribed over the intervention period
Incidence of Serious Adverse Events (SAEs).
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.

Secondary Outcome Measures

Exercise feasibility: Relative dose intensity of exercise
The actual dose relative to the prescribed minimum dose
Exercise feasibility: Early termination of exercise sessions
Termination of an exercise session before the prescribed exercises have been performed
Exercise feasibility: Exercise intervention interruptions
Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session
Exercise feasibility: Permanent discontinuation
Incidence of permanent withdrawal from the intervention before intervention period has ended.
Body composition and anthropometrics: Total lean mass
Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)
Body composition and anthropometrics: Appendicular lean mass
Changes in appendicular lean mass, assessed by DXA
Body composition and anthropometrics: Total fat mass
Changes in total fat mass, assessed by DXA
Body composition and anthropometrics: Fat percentage
Changes in fat percentage, assessed by DXA
Body composition and anthropometrics: Bone mineral density
Changes in bone mineral density, assessed by DXA
Body composition and anthropometrics: Muscle thickness
Changes in thickness of the vastus lateralis, assessed by ultrasound
Body composition and anthropometrics: Skeletal muscle index
Changes in skeletal muscle index, assessed by diagnostic CT scans
Body composition and anthropometrics: Skeletal muscle attenuation
Changes in skeletal muscle attenuation, assessed by diagnostic CT scans
Body composition and anthropometrics: Adipose tissue index
Changes in adipose tissue index, assessed by diagnostic CT scans
Body composition and anthropometrics: Body mass
Changes in body mass
Body composition and anthropometrics: Body mass index
Changes in body mass index
Body composition and anthropometrics: Hip circumference
Changes in hip circumference
Body composition and anthropometrics: Waist circumference
Changes in waist circumference
Muscle strength: Leg press maximal muscle strenght
Changes in leg press one repetition maximum (1RM)
Muscle strength: Chest press maximal muscle strenght
Changes in chest press 1RM
Muscle strength: Hand grip strenght
Changes in hand grip strength, assessed using a dynamometer
Functional performance: Habituel gait speed
Changes in habitual gait speed
Functional performance: Maximal gait speed
Changes in maximal gait speed
Functional performance: Sit-to-stand
Changes in sit-to-stand power.
Functional performance: Stair climb
Changes in stair climbing power
Resting metabolic rate
Changes in resting metabolic rate
Blood pressure: Systolic blood pressure
Changes in systolic blood pressure
Blood pressure: Diastolic blood pressure
Changes in diastolic blood pressure
Heart rate
Changes in resting heart rate
1 and 2-years cancer-specific survival
Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization
1 and 2-years over-all survival
Proportion of patients who have not died 1 and 2 years after randomization
Progression-free survival
Time to progression
Treatment tolerance: Hospitalization
Unscheduled hospitalization
Treatment tolerance: Relative dose intensity
Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Treatment tolerance: Number of series recieved
Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)
Treatment tolerance: Tolerated dose
Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Treatment tolerance: Permanent discontinuation of the treatment
Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Treatment effect: Response to chemotherapy
Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)
Health-related quality of life: Physical well-being
Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) (scale-scoring 0-28, the higher the score the better quality of life)
Health-related quality of life: Social well-being
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Health-related quality of life: Emotional well-being
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)
Health-related quality of life: Functional well-being
Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Health-related quality of life: gastroesophageal cancer specific
Changes in patient-reported gastroesophageal cancer specific well-being assessed using FACT-E (scale-scoring 0-68, the higher the score the better quality of life)
Health-related quality of life: cancer cachexia specific
Changes in patient-reported cancer cachexia specific well-being assessed using Functional Assessment of Cancer Therapy - Cancer Cachexia (scale-scoring 0-48, the higher the score the better quality of life)
Depression
Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)
Anxiety
Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)
Self-reported physical activity: Walking
Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)
Self-reported physical activity: Moderate intensity physical activity (PA)
Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ
Self-reported physical activity: Vigorous intensity PA
Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ
Self-reported physical activity: Total PA
Changes in patient-reported weekly duration of total PA, assessed using the IPAQ (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)
Self-reported physical activity: Sitting time
Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ
Self-reported screening of sarcopenia
Changes in patient-reported signs of sarcopenia, assessed using The Strength, assistance in walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire (scale scoring: 0-10, the higher the score the better the condition)
Self-reported three-days dietary records
Changes in patient-reported three-day record of dietary intake assessed using questionnaries.
Patient-reported symptomatic adverse events
Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Full Information

First Posted
December 2, 2022
Last Updated
April 27, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05650827
Brief Title
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Official Title
Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death. Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy. A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-esophageal Cancer
Keywords
Exercise oncology, Resistance exercise, Cancer, Cancer cachexia, Protein supplements, Sarcopenia, Palliative chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Participants allocated to control receive first line chemotherapy the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. Participants allocated to control are allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise training program. There will be no diet restrictions.
Arm Title
Exercise and protein supplements intervention group
Arm Type
Experimental
Arm Description
Participants allocated to intervention receive first line chemotherapy and the standard patient care program, as provided by Rigshospitalet, Copenhagen, Denmark. The intervention consists of resistance training and a daily protein supplement.
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
10 weeks of resistance training 3 times pr. week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement
Intervention Description
A daily supplement of protein to ensure a daily intake of 1,6g protein/kg bodyweight
Primary Outcome Measure Information:
Title
Exercise feasibility: Exercise sessions attendance
Description
The number of attended exercise training sessions relative to the number of planed exercise sessions
Time Frame
From baseline until end of intervention (10 weeks)
Title
Exercise feasibility: Relative dose-intensity of protein supplement
Description
The actual amount consumed relative to the amount prescribed over the intervention period
Time Frame
From baseline until end of intervention (10 weeks)
Title
Incidence of Serious Adverse Events (SAEs).
Description
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.
Time Frame
Baseline until end of intervention (10 weeks)
Secondary Outcome Measure Information:
Title
Exercise feasibility: Relative dose intensity of exercise
Description
The actual dose relative to the prescribed minimum dose
Time Frame
Baseline until end of intervention (10 weeks)
Title
Exercise feasibility: Early termination of exercise sessions
Description
Termination of an exercise session before the prescribed exercises have been performed
Time Frame
Baseline until end of intervention (10 weeks)
Title
Exercise feasibility: Exercise intervention interruptions
Description
Incidence of exercise intervention disruptions, defined as a period of ≥ 7 days without an attended exercise session
Time Frame
Baseline until end of intervention (10 weeks)
Title
Exercise feasibility: Permanent discontinuation
Description
Incidence of permanent withdrawal from the intervention before intervention period has ended.
Time Frame
Baseline until end of intervention (10 weeks)
Title
Body composition and anthropometrics: Total lean mass
Description
Changes in total lean mass, assessed by dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Appendicular lean mass
Description
Changes in appendicular lean mass, assessed by DXA
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Total fat mass
Description
Changes in total fat mass, assessed by DXA
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Fat percentage
Description
Changes in fat percentage, assessed by DXA
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Bone mineral density
Description
Changes in bone mineral density, assessed by DXA
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Muscle thickness
Description
Changes in thickness of the vastus lateralis, assessed by ultrasound
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Skeletal muscle index
Description
Changes in skeletal muscle index, assessed by diagnostic CT scans
Time Frame
At diagnose, after 10 weeks intervention and at 1 year follow up
Title
Body composition and anthropometrics: Skeletal muscle attenuation
Description
Changes in skeletal muscle attenuation, assessed by diagnostic CT scans
Time Frame
At diagnose, end of week 10
Title
Body composition and anthropometrics: Adipose tissue index
Description
Changes in adipose tissue index, assessed by diagnostic CT scans
Time Frame
At diagnose, end of week 10
Title
Body composition and anthropometrics: Body mass
Description
Changes in body mass
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Body mass index
Description
Changes in body mass index
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Hip circumference
Description
Changes in hip circumference
Time Frame
Baseline, end of week 10
Title
Body composition and anthropometrics: Waist circumference
Description
Changes in waist circumference
Time Frame
Baseline, end of week 10
Title
Muscle strength: Leg press maximal muscle strenght
Description
Changes in leg press one repetition maximum (1RM)
Time Frame
Baseline, end of week 10
Title
Muscle strength: Chest press maximal muscle strenght
Description
Changes in chest press 1RM
Time Frame
Baseline, end of week 10
Title
Muscle strength: Hand grip strenght
Description
Changes in hand grip strength, assessed using a dynamometer
Time Frame
Baseline, end of week 10
Title
Functional performance: Habituel gait speed
Description
Changes in habitual gait speed
Time Frame
Baseline, end of week 10
Title
Functional performance: Maximal gait speed
Description
Changes in maximal gait speed
Time Frame
Baseline, end of week 10
Title
Functional performance: Sit-to-stand
Description
Changes in sit-to-stand power.
Time Frame
Baseline, end of week 10
Title
Functional performance: Stair climb
Description
Changes in stair climbing power
Time Frame
Baseline, end of week 10
Title
Resting metabolic rate
Description
Changes in resting metabolic rate
Time Frame
Baseline, end of week 10
Title
Blood pressure: Systolic blood pressure
Description
Changes in systolic blood pressure
Time Frame
Baseline, end of week 10
Title
Blood pressure: Diastolic blood pressure
Description
Changes in diastolic blood pressure
Time Frame
Baseline, end of week 10
Title
Heart rate
Description
Changes in resting heart rate
Time Frame
Baseline, end of week 10
Title
1 and 2-years cancer-specific survival
Description
Proportion of patients who have not died from gastroesophageal cancer 1 and 2 years after randomization
Time Frame
Randomization to 1 and 2 years after randomization
Title
1 and 2-years over-all survival
Description
Proportion of patients who have not died 1 and 2 years after randomization
Time Frame
Randomization to 1 and 2 years after randomization
Title
Progression-free survival
Description
Time to progression
Time Frame
Randomization to 2 years after randomization
Title
Treatment tolerance: Hospitalization
Description
Unscheduled hospitalization
Time Frame
3, 6 and 9 weeks after randomization
Title
Treatment tolerance: Relative dose intensity
Description
Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Time Frame
3, 6 and 9 weeks after randomization
Title
Treatment tolerance: Number of series recieved
Description
Treatment tolerance assessed by the delivery of chemotherapy (number of series recieved)
Time Frame
3, 6 and 9 weeks after randomization
Title
Treatment tolerance: Tolerated dose
Description
Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Time Frame
3, 6 and 9 weeks after randomization
Title
Treatment tolerance: Permanent discontinuation of the treatment
Description
Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Time Frame
3, 6 and 9 weeks after randomization
Title
Treatment effect: Response to chemotherapy
Description
Response to chemotherapy assessed by Response Evaluation Criteria in Solid Tumors 1.1 (complete response, partiel response, stable disease, progressive disease)
Time Frame
Randomization to 2 years after randomization
Title
Health-related quality of life: Physical well-being
Description
Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) (scale-scoring 0-28, the higher the score the better quality of life)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Health-related quality of life: Social well-being
Description
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Health-related quality of life: Emotional well-being
Description
Changes in patient-reported social well-being assessed using FACT-E (scale-scoring 0-24, the higher the score the better quality of life)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Health-related quality of life: Functional well-being
Description
Changes in patient-reported functional well-being assessed using FACT-E (scale-scoring 0-28, the higher the score the better quality of life)
Time Frame
Baseline,10 weeks-, 1 year-, 2 years after randomization
Title
Health-related quality of life: gastroesophageal cancer specific
Description
Changes in patient-reported gastroesophageal cancer specific well-being assessed using FACT-E (scale-scoring 0-68, the higher the score the better quality of life)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Health-related quality of life: cancer cachexia specific
Description
Changes in patient-reported cancer cachexia specific well-being assessed using Functional Assessment of Cancer Therapy - Cancer Cachexia (scale-scoring 0-48, the higher the score the better quality of life)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Depression
Description
Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Anxiety
Description
Changes in patient-reported anxiety, assessed using the HADS (scale scoring: 0-21, the higher the score the worse the condition)
Time Frame
Baseline, 10 weeks-, 1 year-, and 2 years after randomization
Title
Self-reported physical activity: Walking
Description
Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ)
Time Frame
Baseline, end of week 10
Title
Self-reported physical activity: Moderate intensity physical activity (PA)
Description
Changes in patient-reported weekly duration of moderate intensity PA, assessed using the IPAQ
Time Frame
Baseline, end of week 10
Title
Self-reported physical activity: Vigorous intensity PA
Description
Changes in patient-reported weekly duration of vigorous intensity PA, assessed using the IPAQ
Time Frame
Baseline, end of week 10
Title
Self-reported physical activity: Total PA
Description
Changes in patient-reported weekly duration of total PA, assessed using the IPAQ (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week)
Time Frame
Baseline, end of week 10
Title
Self-reported physical activity: Sitting time
Description
Changes in patient-reported weekly duration of sitting time, assessed using the IPAQ
Time Frame
Baseline, end of week 10
Title
Self-reported screening of sarcopenia
Description
Changes in patient-reported signs of sarcopenia, assessed using The Strength, assistance in walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire (scale scoring: 0-10, the higher the score the better the condition)
Time Frame
Baseline, end of week 10
Title
Self-reported three-days dietary records
Description
Changes in patient-reported three-day record of dietary intake assessed using questionnaries.
Time Frame
Baseline, week 5 and week 10
Title
Patient-reported symptomatic adverse events
Description
Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame
One week after each serie of chemotherapy during the intervention (10 weeks)
Other Pre-specified Outcome Measures:
Title
Blood biochemistry: Leukocyte differential counts
Description
Changes in differential counts (total and per type: eosinofils, basofils, neutrofils, monocytes and lymphocytes)
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: C-reactive protein
Description
Changes in C-reactive protein
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: albumin and protein
Description
Changes in albumine and protein
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: magnesium and phosphate
Description
Changes in magnesium and phosphate
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Total cholesterol
Description
Changes in total cholesterol
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Low-density lipoprotein cholesterol
Description
Changes in low-density lipoprotein cholesterol
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: High-density lipoprotein cholesterol
Description
Changes in high-density lipoprotein cholesterol
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Triglyceride
Description
Changes in triglyceride
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Glycated hemoglobin A1c
Description
Changes in glycated hemoglobin A1c
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Insulin
Description
Changes in insulin
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Glucose tolerance
Description
Changes in glucose tolerance (2-hpur oral glucose tolerance test)
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Glucose
Description
Changes in glucose
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: C-peptide
Description
Changes in c-peptide
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Interleukin-1
Description
Changes in interlieukin-1
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Interleukin-6
Description
Changes in interlieukin-6
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Interleukin-8
Description
Changes in interlieukin-8
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Interleukin-10
Description
Changes in interlieukin-10
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Interferon-gamma
Description
Changes in interferon-gamma
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Tumor necrosis factor-alpha
Description
Changes in tumor necrosis factor-alpha
Time Frame
Baseline, end of week 10
Title
Blood biochemistry: Circulating tumor DNA
Description
Changes in circulating tumor DNA
Time Frame
Baseline, week 5 and 10
Title
Effect of acute exercise: Insulin sensitivity
Description
Muscle glucose uptake during insulin stimulation after acute exercise
Time Frame
Immediately after acute exercise
Title
Effect of acute exercise: muscle protein synthesis
Description
Muscle protein synthesis during insulin stimulation after acute exercise.
Time Frame
Immediately after acute exercise
Title
Changes of proteins in muscle biopsies
Description
Modifications of proteins after acute exercise. Muscle biopsies will be subjected to mass spectrometry-based proteomic analysis.
Time Frame
Before and immediately after acute exercise
Title
Changes of proteins in mithocondrial regulation
Description
Modifications of mithochondrial regulation. Signaling of mitochondiral fission, fusion and mitophagy will be examined in mucle biopsies.
Time Frame
Before and immediately after acute exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction referred to first line chemotherapy. Exclusion Criteria: Age < 18 Living outside the greater Copenhagen area Any other malignancy requiring active treatment Not eligible for chemotherapy Performance status > 2 Not able to swallow liquids Parenteral nutrition or enteral nutrition via feeding tube Physical or mental disabilities that prohibit execution of test or training procedures Pregnancy Inability to understand the Danish language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rikke Krabek, MD
Phone
+4535457641
Email
rikke.krabek@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casper Simonsen, PhD
Organizational Affiliation
Copenhagen University Hospital, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rikke Krabek

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer

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